check_circleStudy Completed

Bronchitis, Chronic, Bronchial Diseases

Bayer Identifier:

12219

ClinicalTrials.gov Identifier:

NCT00932802

EudraCT Number:

Not Available

EU CT Number:

Not Available
Greatest International Antiinfective Trial with Avelox

Trial purpose

The observation period for each patient covered an initial treatment period with Avelox® plus optional 2 long-term follow-up periods (6 and 12 months).For each patient, the physician documented data at any initial visit (baseline) and at least one short-term follow-up visit (=initial treatment period).Optionally, long-term follow-ups (6 and 12 months) were documented, and a patient questionnaire was filled in.

Key Participants Requirements

Sex

Both

Age

12 Years
  • - Outpatients with diagnosis of AECB and decision taken by the investigator to prescribe moxifloxacin
  • - Exclusion criteria must be read in conjunction with the local product information

Trial summary

Enrollment Goal
50000
Trial Dates
February 2004 - November 2007
Phase
N/A
Could I Receive a placebo
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany
Completed
Many Locations, Austria
Completed
Many Locations, Brazil
Completed
Many Locations, Switzerland
Completed
Many Locations, China
Completed
Many Locations, Hong Kong
Completed
Many Locations, Croatia
Completed
Many Locations, Indonesia
Completed
Many Locations, Morocco
Completed
Many Locations, Netherlands
Completed
Many Locations, El Salvador
Completed
Many Locations, Colombia
Completed
Many Locations, Egypt
Completed
Many Locations, Hungary
Completed
Many Locations, Mexico
Completed
Many Locations, Malaysia
Completed
Many Locations, Philippines
Completed
Many Locations, Pakistan
Completed
Many Locations, Poland
Completed
Many Locations, Singapore
Completed
Many Locations, Slovenia
Completed
Many Locations, Turkey
Completed
Many Locations, Taiwan
Completed
Many Locations, South Korea

Primary Outcome

  • Evaluation of impact of AECB on the patient and the community as well as effect and safety of a treatment with moxifloxacin tablets in daily life clinical practice
    date_rangeTime Frame:
    During documentation at baseline and at at least one short-term follow-up visit; at maximum two short-term (within ca. 14 days) and two long-term follow-up visits (after ca. 6 and 12 months).
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    Safety Issue:
    yes

Secondary Outcome

  • Course of symptom relief
    date_rangeTime Frame:
    During documentation of up to two short-term follow-up visits (within ca. 14 days)
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    Safety Issue:
    no
  • Speed of return to normal daily life activities
    date_rangeTime Frame:
    During documentation of the last short-term follow-up visit (after ca. 14 days)
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    Safety Issue:
    no
  • Adverse events collection
    date_rangeTime Frame:
    Throughout the entire study, whenever Adverse Events occur
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    Safety Issue:
    Yes
  • Evaluation of frequency of new exacerbations
    date_rangeTime Frame:
    During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)
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    Safety Issue:
    No
  • Progression of chronic respiratory disease
    date_rangeTime Frame:
    During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)
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    Safety Issue:
    No

Trial design

GIANT - Greatest International Antiinfective Trial with Avelox®
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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